Financial Toxicity and Quality of Life in Patients With Testicular Germ Cell Tumors
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.
Overview
Brief Summary
This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age \> 18 years of age
- •Patients with histologically or clinically confirmed germ cell tumor.
- •Completed treatment for germ cell tumor with multicycle (\> 2 cycles) / multiagent chemotherapy.
- •Within years 1-5 of surveillance since Day 1 of last cycle of chemotherapy
- •Signed informed consent
Exclusion Criteria
- •Long-term survivors
- •Patients undergoing active chemotherapy
- •Patients who did not complete 1st line chemotherapy.
Outcomes
Primary Outcomes
Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.
Time Frame: 5 years
Secondary Outcomes
- Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.(5 years)